Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:22 AM
Study NCT ID:
NCT07453303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Geriatric Assessment in Adults Aged 40 Years and Older Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Frailty', 'timeFrame': 'Baseline', 'description': 'Frailty status assessed using a validated frailty assessment tool and defined according to established criteria in adults aged 40 years and older living with HIV and age- and sex-matched healthy controls.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV Infections'], 'conditions': ['Frailty', 'Sarcopenia']}, 'descriptionModule': {'briefSummary': 'People living with HIV are experiencing longer life expectancy due to effective antiretroviral therapy; however, they may develop age-related conditions earlier than the general population. This prospective observational study aims to evaluate frailty, sarcopenia, nutritional status, cognitive function, and functional performance in adults aged 40 years and older living with HIV and to compare them with age- and sex-matched healthy controls.', 'detailedDescription': 'With the widespread use of antiretroviral therapy, individuals living with HIV have achieved near-normal life expectancy. However, emerging evidence suggests that chronic inflammation, immune activation, and long-term treatment exposure may contribute to accelerated or premature aging processes. Frailty, sarcopenia, cognitive decline, and functional impairment have been increasingly reported in middle-aged and older adults living with HIV.\n\nThis prospective observational cohort study aims to perform a comprehensive geriatric assessment in adults aged 40 years and older living with HIV and to compare the findings with age- and sex-matched healthy controls. The assessment will include evaluation of frailty, sarcopenia, nutritional status, cognitive function, and functional performance using standardized clinical tools.\n\nThe primary objective is to determine the prevalence and characteristics of geriatric vulnerabilities in adults aged ≥40 years living with HIV. Secondary objectives include identifying factors associated with frailty and functional impairment in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults aged 40 years and older living with HIV who are followed in the infectious diseases outpatient clinic and age- and sex-matched healthy controls recruited from the community or hospital staff.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Age ≥ 40 years\n\nConfirmed diagnosis of HIV infection (for HIV group)\n\nOn stable antiretroviral therapy for at least 6 months (for HIV group)\n\nHIV-negative status confirmed by medical history or testing (for control group)\n\nAbility to provide informed consent\n\nExclusion Criteria:\n\nAcute infection or hospitalization within the last 4 weeks\n\nKnown active malignancy under treatment\n\nSevere psychiatric disorder interfering with assessment\n\nSevere cognitive impairment preventing participation'}, 'identificationModule': {'nctId': 'NCT07453303', 'acronym': 'HIV-AGE40', 'briefTitle': 'Comprehensive Geriatric Assessment in Adults Aged 40 Years and Older Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital'}, 'officialTitle': 'Prospective Comparative Evaluation of Frailty, Sarcopenia, Nutritional Status, Cognitive Function, and Functional Performance in Adults Aged 40 Years and Older Living With HIV and Age- and Sex-Matched Healthy Controls', 'orgStudyIdInfo': {'id': 'TKD-GER-2026-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV-Positive Participants', 'description': 'Adults aged 40 years and older with confirmed HIV infection receiving antiretroviral therapy and undergoing comprehensive geriatric assessment.'}, {'label': 'Healthy Controls', 'description': 'Age- and sex-matched HIV-negative adults aged 40 years and older undergoing the same comprehensive geriatric assessment.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}